meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
36
Latest Decision
1992-08-21

Clearances · page 95 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K921468 PERMAMESH HYDROXYLAPATITE MATRIX Ceramed Corp. LYC Class II 1992-08-21
K922755 PULPDENT HARD CORE Pulpdent Corp. EBF Class II 1992-08-20
K921538 AMALGAPHASE Saskan Amalgam Alloys, Inc. EJJ Class II 1992-08-10
K921564 POLYCLEAN Medical Polymers, Inc. EFB Class I 1992-08-10
K911575 ANCHOR IMPLANT DENTAL ATTACHMENTS Anchor Implant Systems, Inc. DZE Class II 1992-08-10
K922638 TEMPIT-E Centrix, Inc. EMA Class II 1992-08-10
K922853 AQUA IONOFIL Voco GmbH EMA Class II 1992-08-10
K922175 HEALTHPAK CHAIR SOX BARRIERS Healthpak, Inc. KLC Class I 1992-08-06
K922633 CAVI-ZYME E&D Dental Products, Inc. EJB Class I 1992-08-06
K922854 AQUA MERON Voco GmbH EMA Class II 1992-08-05
K922448 BENCHMARK I J.F. Jelenko & Co., Inc. EJS Class II 1992-08-05
K923306 HEALTHPAK UTILITY SOX BARRIERS Healthpak, Inc. KLC Class I 1992-08-05
K922449 PA-400 J.F. Jelenko & Co., Inc. EJS Class II 1992-08-05
K922450 BENCHMARK C J.F. Jelenko & Co., Inc. EJS Class II 1992-08-05
K922451 LEGACY-XT J.F. Jelenko & Co., Inc. EJS Class II 1992-08-05
K922446 ACCU-STAR J.F. Jelenko & Co., Inc. EJS Class II 1992-08-05
K922447 BENCHMARK III J.F. Jelenko & Co., Inc. EJS Class II 1992-08-05
K922615 COLTENE A.R.T. BOND Coltene/Whaledent, Inc. KLE Class II 1992-08-03
K922499 REFLECTIONS - CERAMIC DENTAL BRACKET Cdb Corp. EJF Class I 1992-07-30
K920645 ORTHODONTIC ELASTICS BANDS Masel Industries, Inc. EJF Class I 1992-07-28
K922721 VLC DYCAL II Dentsply Intl. EJK Class II 1992-07-23
K915733 STERI-OSS DRILLS AND TAPS Steri-Oss, Inc. DZE Class II 1992-07-17
K922569 TETRIC LIGHT-CURING COMPOSITE Ivoclar North America, Inc. EBF Class II 1992-07-15
K920928 PRE-STERILIZED ITI DENTAL IMPLANTS The Straumann Co. DZE Class II 1992-07-15
K921801 MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM Techmedica, Inc. JEY Class II 1992-07-15
K921772 BIOLOR Degussa AG EJT Class II 1992-07-13
K921773 TX ELECTRIC TOOTHBRUSH Optiva Corp. JEQ Class I 1992-07-13
K921933 O BUTMENT HB O Co., Inc. DZE Class II 1992-07-08
K921623 VITADUR ALPHA PORCELAIN Vident EIH Class II 1992-07-02
K921619 DENTAL PORCELAIN Dentsply Intl. EIH Class II 1992-07-02
K921794 CERADELTA 2 Metalor Dental USA Corp. EJT Class II 1992-07-02
K921469 OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH Ceramed Corp. LYC Class II 1992-06-25
K922077 MODIFIED SITE POWER HANDPIECE Chiron Vision Corp. EKX Class I 1992-06-23
K913644 VITA IN-CERAM Vident EIH Class II 1992-06-22
K921479 DUCERATIN/DUCERAM LFC DENTAL PORCELAIN Degussa AG EIH Class II 1992-06-22
K921246 IMZ SURGICAL INSTRUMENT TRAY Interpore Intl. DZE Class II 1992-06-22
K921474 VITA OMEGA PORCELAIN Vident EIH Class II 1992-06-18
K922307 SHOWERFLOSS ORAL IRRIGATION UNIT Showerfloss, Inc. EFS Class I 1992-06-16
K921601 ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE Ultradent Products, Inc. JES Class I 1992-06-16
K922380 BITE RIM WAX Dentsply Intl. EGD Class I 1992-06-16
K921820 RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION Cosmedent, Inc. EBF Class II 1992-06-16
K921701 DURAFILL BOND Heraeus Kulzer, Inc. KLE Class II 1992-06-09
K915375 ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM Odontit Systeme DZE Class II 1992-06-03
K922203 IPT CAPSULE MIXER Ipt Technologies, Inc. EFD Class I 1992-06-03
K921999 INTERJET(TM) GINGIVAL CARE INSTRUMENT Bausch & Lomb, Inc. EFS Class I 1992-06-03
K920644 F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND Fairform Mfg., Co., Ltd. JEQ Class I 1992-05-29
K921445 DEGUBOND PLUS Degussa AG EJS Class II 1992-05-26
K921419 DEVA PLUS Degussa AG EJS Class II 1992-05-26
K921439 BISCO CORE PASTE Bisco, Inc. EBF Class II 1992-05-11
K920492 HIGH VAC Hygoplastic, Inc. DYN Class I 1992-05-11
K920922 GDC 3367 Deringer-Ney, Inc. EJS Class II 1992-05-05
K921117 MINIDAM Delsan Dental Systems DYN Class I 1992-05-05
K921245 THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II Ormco Corp. DYH Class II 1992-05-05
K913688 BUD MAXILLOFACIAL IMPLANT SYSTEM Bud Industries, Inc. JEY Class II 1992-05-05
K915507 E-Z GOLD TOOTH FILLING MATERIAL Lloyd Baum Center, Inc. EJT Class II 1992-05-05
K920710 AIR MEDICA III Hinatawada Seimitsu Mfg. Co., Ltd. EIA Class I 1992-05-04
K920499 SANI-TIP Dw Industries, Inc. ECB Class I 1992-05-03
K920485 PUPLDENT ETCH N PREP Pulpdent Corp. EBF Class II 1992-04-29
K920483 10% PHOSPHORIC ACID ETCHING GEL Pulpdent Corp. EBF Class II 1992-04-29
K920484 2.5% NITRIC ACID ETCHING GEL Pulpdent Corp. EBF Class II 1992-04-28
K920460 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL Pulpdent Corp. ELL Class II 1992-04-28
K920482 14% HYDROFLUORIC ACID ETCHING GEL Pulpdent Corp. EBF Class II 1992-04-28
K920189 GX-C CEPHALOMETER Gendex Corp. EAG Class II 1992-04-28
K920758 JENKER NEEDLE STICK PROTECTOR Dentsply Intl. DZM Class I 1992-04-28
K914178 CORRECTED-V.P.S. Jeneric/Pentron, Inc. ELW Class II 1992-04-28
K921406 SILICONT BUR BLOCK Innovators, Inc. EJL Class I 1992-04-28
K920692 SEPTOCALCINE ULTRA Specialites Septodont EJK Class II 1992-04-21
K920613 DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL Ivoclar North America, Inc. EJS Class II 1992-04-21
K921385 IMPROVED SEQUENCE LIGHT CURE ADHESIVE Ormco Corp. DYH Class II 1992-04-21
K915668 BISCO CAVITY CLEANSER Bisco, Inc. EBF Class II 1992-04-21
K913089 WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS Wilde-USA, Inc. EBF Class II 1992-04-21
K915165 ARGEBOND 77+ Argen Precious Metals, Inc. EJS Class II 1992-04-21
K920781 FLASH BOND Advanced Orthodontics Systems, Inc. DYH Class II 1992-04-21
K915250 WIL-PDS & WIL-PDI CASTING ALLOYS Wilde-USA, Inc. EJH Class II 1992-04-21
K920768 HOLLOW SCREW IMPLANTS 6MM, 14MM, 16MM The Straumann Co. DZE Class II 1992-04-21
K920060 DENTAL SOLDER ALLOY Deringer-Ney, Inc. EJT Class II 1992-04-02
K914317 ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL Confi-Dental Products Co. DYH Class II 1992-03-26
K920534 PORCELAIN PRIMER Confi-Dental Products Co. DYH Class II 1992-03-26
K920244 DW240 #73C ALLOY FOR PORCELAIN FUSED TO METAL Ivoclar North America, Inc. EJT Class II 1992-03-26
K920243 SMART BURS TOTAL CARBIDES Vermont Diamond Instruments EJL Class I 1992-03-25
K912990 CONVERBASE Wilde-USA, Inc. EBI Class II 1992-03-25
K915666 AMALCODEN Mion International Corp. EMA Class II 1992-03-25
K920425 3M BRAND RESTORATIVE Z100 3M Company EBF Class II 1992-03-20
K920784 ORTHODONTIC FACE BOW W/ INNER WIRE Gac Intl., Inc. DZB Class II 1992-03-20
K920424 SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM 3M Company KLE Class II 1992-03-20
K920557 WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX Wilde-USA, Inc. EBI Class II 1992-03-20
K914318 GLASS IONOMER CEMENT Confi-Dental Products Co. EMA Class II 1992-03-20
K915543 NEW OPAQUE PORCELAIN Dentsply Intl. EIH Class II 1992-03-19
K920887 GDC-3338, DENTAL SOLDER ALLOY Deringer-Ney, Inc. EJS Class II 1992-03-19
K914513 PALAVIT G Heraeus Kulzer, Inc. EGD Class I 1992-03-19
K920365 TOOTH BONDING AGENT Voco GmbH EBF Class II 1992-03-19
K920883 HEMOSTAT, SURGICAL (VARIOUS TYPES) S.T.S Instruments EMD Class I 1992-03-13
K914456 DENTACOLOR(R) CRE-ACTIVE Heraeus Kulzer, Inc. EBF Class II 1992-03-11
K914562 ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM Aseptic Dental Technologies, Inc. DZM Class I 1992-03-09
K914325 ROOT CANAL FILLING CEMENT Confi-Dental Products Co. KIF Class II 1992-03-09
K915511 MIRAGE COMPLETE KIT AND MIRAGE ABC KIT Mirage Dental Systems KLE Class II 1992-03-06
K911735 ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT Artech Corp. DZE Class II 1992-03-05
K920017 IMPROVED DENTAL OPERATING LIGHT Den-Tal-Ez Mfg Co., Inc. KLC Class I 1992-03-02
K920560 DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL Invoclar North America, Inc. EJS Class II 1992-03-02
K914476 VITAPAN ACRYLIC DENTURE TEETH Vident ELM Class II 1992-03-02

12,679 clearances in the Dental panel. Data: openFDA.